Coronavirus Florida: Antibody tests are hitting the market, but are they accurate?

Sam Howard @SamuelHHoward

Thursday

Apr 9, 2020 at 3:50 PM

Coronavirus Palm Beach County updates: A private clinic in Jupiter plans to administer rapid tests to indicate whether someone had the coronavirus.

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JUPITER — Wondering if that bug you had last month was the coronavirus?

Leaders at a clinic on Military Trail in Jupiter say they have rapid tests that can help pinpoint if you had COVID-19. The Medical Group of South Florida received its first batch of 625 tests Thursday.

Some have placed great hope in the role these tests, which gauge the presence of antibodies associated with the coronavirus, and hope they could play a key role in resolving the pandemic. They say the tests could give Americans peace of mind and get them back to work as the economy reels.

However, public health leaders in the U.S. and abroad are cautious about antibody tests, which have essentially been authorized to fast-track around Food and Drug Administration protocol.

At the Jupiter clinic, more than 500 people have already scheduled appointments to be tested, CEO and owner Joshua Smith said Wednesday. At least one other Palm Beach County clinic, Palm Beach Thyroid and Endocrinology Wellness LLC, has announced similar plans.

"I think there’s a huge concern in the community about current infection and potential infection in the past few months of whether the person had been exposed to COVID," said Dr. Avishai Mendelson, the Jupiter group’s medical director.

How the tests work

The tests are conducted via pinprick and can return results in about 15 minutes without being sent to a lab, according to information from Henry Schein and National Bio+Green Sciences LLC, both of which are behind tests that Smith ordered.

The presence of certain antibodies, which help the body fight off illness, suggests that an individual was infected with the coronavirus, built up an immune response and recovered.

The jury is still out whether that means someone is immune in the future, said Dr. Terry Adirim, senior associate dean for clinical affair at Florida Atlantic’s Schmidt College of Medicine.

But if the antibodies are there, Adirim said "it’s very likely" the person is at least immune for this wave of the virus.

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There are things to keep in mind about the tests, known as serology or antibody tests.

The ones ordered in Jupiter don’t have final approval from the U.S. Food and Drug Administration, Smith said. The FDA issued a policy last month saying it would not object to these types of tests as long as they are validated, the agency is notified about them and the test kits include warning statements.

At a press briefing Tuesday, White House Coronavirus Task Force Coordinator Dr. Deborah Birx threw cold water on the state of many antibody tests.

Tests available online may "give you a false reassurance ... that you may be protected" from the coronavirus, Birx said.

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Also on Tuesday, the FDA issued a statement criticizing those who falsely say antibody tests can diagnose for COVID-19 or describe the products as FDA approved. The agency said it would take "appropriate action" against those firms, which went unnamed.

Potential to donate plasma

In the United Kingdom, Government Adviser on Life Sciences John Bell wrote in a blog post Sunday that he’s yet to validate a "good test" that can be used at home.

"Sadly, the tests we have looked at to date have not performed well," wrote Bell, also a University of Oxford professor. "We see many false negatives ... and we also see false positives."

That is precisely the concern from Adirim. She worries some tests could respond to antibodies associated with other viruses.

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With an ideal product, such testing could be vital for public health, said Adirim, a former federal public health official herself.

"If we do this widespread, I think it will tell us how many people have been exposed and infected," Adirim said. "And we’ll be able to get a better idea of at what point we can go out."

There’s also the potential for coronavirus survivors to donate their plasma. Scientists are looking into whether donations could help treat those currently sick with COVID-19

The FDA lists antibody tests that it's been notified are operating under a policy issued last month. The list includes tests distributed by Henry Schein, but makes no mention of National Bio+Green Sciences.

An individual reached Thursday morning at New Jersey-based National Bio+Green Sciences said the company is pursuing a separate FDA process, what’s known as an emergency use authorization request. They said their request is pending and that the company has "clearance to distribute."

The person hung up the phone before identifying themselves and did not respond to another request for comment. The test distributor, Gulf Coast Pharmaceuticals Plus, did not respond to a voicemail.

How much does a test cost?

Smith said tests he’s ordered still needed some level of government clearance and Mendelson added that other types of serology tests are already common.

"This is based on the same science," Mendelson said. "The science and data are available to us from the manufacturer."

Leaders at Palm Beach Thyroid and Endocrinology Wellness, the other local establishment pursuing antibody tests, did not respond to a request for comment Thursday. That clinic has locations near Wellington and west of Boynton Beach.

At The Medical Group of South Florida, tests cost $150 out-of-pocket, marketing director Maeve Greenaway said. The clinic is prioritizing requests from its regular patients, but others can be tested after a $39 telehealth appointment, she said.

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Henry Schein said in a recent news release that patients should consider follow-up testing to confirm or rule out an infection. Mendelson added that all sorts of serological tests have some risk of returning a false positive or false negative.

"That’s why these test results need to be discussed with a doctor, to tell you whether you need to have the (nasal swab) testing for the virus."